Multiple sterile zone package



J. L. SORENSON MULTIPLE STERILE ZONE PACKAGE STRUCTURE Filed Oct. 25,1961 March 3, 1964 INVENTOR.

77265 1. farensan aw/8%- ATTO EYS United States Patent 3,123,211MULTIPLE STERILE ZONE PACKAGE STRUCTURE James L. Sorenson, 2341 LoganCircle, Salt Lake City 5, Utah Filed Oct. 25, 1961, Ser. No. 147,661 1Claim. (Cl. 20663.2)

This invention relates to packaging for sterile surgical apparatus orthe like, and more particularly to a multiple sterile zone packagingconstruction.

Heretofore, there has been considerable complexity of construction insurgical instrument packages such as packages for catheters and thelike, with attendant dii'ficulties in maintaining desirable standards ofsterility. The present invention overcomes these difficulties andproblems by means of a multiple zone sterile packaging constructionwherein a first sterile zone is afforded by a plastic, preferably pliantenvelope which may be used for a catheter and a needle, and a secondsterile zone is formed by a fully protective envelope cooperativelysurrounding the apparatus and the envelope forming the first sterilezone.

Further in accordance with the invention, the first sterile zone isreleasably defined by a tear strip or string which may surround theneedle hub in the embodiment referred to, while the second sterile zoneis similarly secured by a tear strip or string at an end of the externalenvelope.

Accordingly, it is an object of the present invention to provide amultiple sterile zone packaging construction for sterile instruments andthe like which permits the security of a basic packaging construction tobe maintained intact despite hazards in shipping, storage and the like.

Another object of the invention is to provide a device as describedwhich permits successive breaching of the security zones so that, forexample, a needle may be utilized upon opening of the outer sterile zoneand the encompassing package, with a second zone being opened whendesired upon use of the needle.

Another object of the invention is to provide a device as describedwherein the needle may be similarly retained in sterile condition by anenvelope which can be penetrated thereby, although it is also within thescope of the invention to utilize a simple, relatively rigid cap for theneedle since the basic apparatus is protected by the outer sterile zone.

Another object of the invention is to provide a device as describedwhich permits access to the successive sterile zones by means of tearstrip or string structures located for ready access as needed.

Yet another object of the invention is to provide a device which issimple in construction, easily manipulated without expensive training orskills for the purpose, and Which is inexpensive to manufacture so thatit may be utilized in automated production lines.

Other objects and advantages of the invention will become apparents asthe description proceeds in accordance with the drawings in which amultiple zone sterile packaging construction is shown according to thepresent invention.

Referring to the drawing, a packaging construction is provided whichincludes an outer envelope 12 of flexible plastic or the like, an innerenvelope 14 of similar flexible plastic or the like, a needle hub 16 insnugly sealing relationship with a reduced end 18 of the envelope 14 andan envelope extension 20 also in preferably sealing relationship withthe hub 16, although being alternatively made as a separable rigid coverin accordance with the understanding of those skilled in the art.

In the embodiment shown, the instrument apparatus includes a needle 22for veni-puncture or the like and of hollow construction for receptionof a catheter 24 extend- 3,123,211 Patented Mar. 3, 1964 ing into thehub 16 and releasably closed by a cap 26 also as understood by thoseskilled in the art.

In order to permit multiple breach of successive sterile zones definedby the packaging construction described, the outer encompassing envelope12 is provided with a tear string or tear strip 27 at at least one endthereof, or at a convenient location for opening the said outerenvelope; and with a closure 28 at the other end, which may be aheat-seal scam in a preferred form of the invention.

Correspondingly, the inner envelope 14 at the reduced neck portion 18thereof is provided With a tear string or strip 2? in juxtaposition withthe hub 16 so that upon opening of the outer envelope by means of thestrip or string 27, the strip or string 29 may be operated to open theinner envelope 14 as hereinafter described.

It will thus be seen that the combined structures disclosed provide anddefine an outer sterile zone 30 between the outer envelope 12 and theinner envelope 14 and associated envelope structure, together with aninner sterile zone 32 specifically defined by the said inner envelope14. In this connection, it may be noted that a further sterile zone 34may be formed by the forward envelope portion 20 when an envelopeextension at the forward portion of the inner apparatus is utilized asshown.

Accordingly, sterility in depth is afforded by the multiple sterile zoneconstruction defined, with the outer sterile zone being breachable bystripping off the tear strip or string 27 to place the inner apparatusin position for immediate use. Until such time, inadvertent destructionof the sterility of the apparatus is precluded.

Thereupon, the needle 22 may be maneuvered through the sac or envelope20 and into a body cavity, as understood by those skilled in the art.Alternatively, an outer elongate rigid cap of polyethylene or the likemay be removed, with the advantage that with the double sterile zoneprovided there is no penetration of the areas around the needle by aloose fit in such a cap, as in previously available devices.

The outer envelope 12 may be maintained in surrounding relationship tothe inner apparatus, or alternatively, may be stripped off so that themanipulation of the catheter 24 may be accomplished through the innersterile zone envelope 14, with the result that even though the outersterile zone is penetrated, a sterile relationship is maintained untilthe ultimate moment of use. Thus, the tear strip or string 29 may betaken olf when full access to the catheter 24 is desired for medicinalinfusions or the like. In this connection, it is noted that whereas thereduced end 18 of the envelope 14 is pro vided with the tear strip 29,the outer end of this envelope may be a heat seal seam 36.

The construction of the invention which affords sterility in depththrough multiple sterile zones, thus has application in a wide varietyof surgical and health situations.

Although I have described my invention with respect to certain specificprinciples in details thereof, it will be understood that the inventionis not limited thereto, but is to be construed in accordance with thescope and spirit of the hereunto appended claims.

I claim as my invention:

In a sterile surgical package, a hollow needle, a hollow hub on saidneedle, a catheter extending into said hub for ultimate advancementthrough said needle, a flexible envelope enclosing said catheter andhaving one end closed and the other end sealed around said hub tomaintain the catheter sterile, a second flexible envelope enclosing saidneedle and having one end in sealing engagement with said hub and theother end closed to maintain said needle sterile, a tear stripassociated with said envelopes around said hub to effect completeremoval of the envelopes one at a time when desired, a third envelopeenclosing the other two envelopes and having both ends closed to providea sterile zone outside the other two envelopes, and a tear strip at oneend of said third envelope, whereby upon removal of the third envelopethe needle may be advanced through the second envelope into the body ofa patient and the catheter advanced while in the first said envelopebefore cornplete removal of the first and second envelopes.

Hill Oct. 26, 1886 Pittenger Jan. 27, 1925 Brewer Mar. 9, 1943 JohnsonMay 25, 1943 Long Nov. 25, 1952 Doherty Sept. 1, 1959 Cutter Dec. 1,1959 Garth Aug. 2, 1960 Bechtold May 1, 1962 Rasmussen et al May 22,1962 Ballard Sept. 25, 1962 FOREIGN PATENTS France Apr. 1, 1953

